PROGEL PLATINUM PLEURAL AIR LEAK SEALANT
Report
- Report Number
- 1213643-2021-20496
- Event Type
- Malfunction
- Date Received
- December 31, 2021
- Date of Event
- November 4, 2021
- Report Date
- September 4, 2024
- Manufacturer
- NEOMEND INC -2953195
- Product Code
- NBE
- UDI-DI
- 00801741010026
- PMA / PMN Number
- P010047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
AS REPORTED, THE PROGEL GLASS VIAL BROKE INSIDE THE SYRINGE CHAMBER DURING APPLICATION, THE BROKEN PIECES WERE IMMEDIATELY REMOVED FROM THE FIELD. THERE WAS NO REPORTED PATIENT HARM/INJURY. CONTACT INFORMATION WAS NOT PROVIDED, THEREFORE, WE ARE UNABLE TO REQUEST ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, AND NOT HAVING THE SAMPLE TO REVIEW, A ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE STATES "DURING APPLICATOR ASSEMBLY, THE PROGEL¿ PUSH ROD IS DESIGNED TO LOCK IN TO THE APPLICATOR HOUSING. FORCED REMOVAL OF THE LOCKING PUSH ROD FROM THE APPLICATOR HOUSING MAY RESULT IN POTENTIAL DAMAGE TO THE APPLICATOR SYSTEM OR THE CHEMISTRY CARTRIDGES." REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN SEPTEMBER 2021. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO CORRECT MEDICAL DEVICE MANUFACTURER AND UDI. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
AS REPORTED, THE PROGEL GLASS VIAL BROKE INSIDE THE SYRINGE CHAMBER DURING APPLICATION, THE BROKEN PIECES WERE IMMEDIATELY REMOVED FROM THE FIELD. THERE WAS NO REPORTED PATIENT HARM/INJURY. CONTACT INFORMATION WAS NOT PROVIDED, THEREFORE, WE ARE UNABLE TO REQUEST ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, AND NOT HAVING THE SAMPLE TO REVIEW, A ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE STATES "DURING APPLICATOR ASSEMBLY, THE PROGEL¿ PUSH ROD IS DESIGNED TO LOCK IN TO THE APPLICATOR HOUSING. FORCED REMOVAL OF THE LOCKING PUSH ROD FROM THE APPLICATOR HOUSING MAY RESULT IN POTENTIAL DAMAGE TO THE APPLICATOR SYSTEM OR THE CHEMISTRY CARTRIDGES." REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION, WITH NO INDICATION OF A MANUFACTURING RELATED CAUSE FOR THE EVENT REPORTED. (B)(4).
THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5105219): "THE PATIENT HAD A RIGHT THORACOTOMY/DECORTICATION SURGERY. THE SURGEON WAS USING SEVERAL OF THE PROGEL SYRINGES DURING THE CASE (PLEURAL AIR LEAK SEALANT). AS HE BEGAN TO INJECT THE PROGEL INTO THE CHEST CAVITY, ONE OF THE SYRINGES BROKE INSIDE THE SYRINGE CHAMBER. HE WAS UNABLE TO GET ANY PROGEL OUT OF THE TIP OF THE SYRINGE AT THIS POINT. A FEW SHARDS FROM THE SYRINGE LANDED ON THE STERILE DRAPE. THE CHEST CAVITY WAS INSPECTED AND NO SYRINGE SHARDS WERE FOUND. THE SYRINGE WAS IMMEDIATELY REMOVED FROM THE FIELD AND STERILITY MAINTAINED. NO HARM CAME TO THE PATIENT. POST-OPERATIVE CHEST X-RAY DOES NOT SHOW FOREIGN BODY IN PATIENT'S CHEST."
THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5105219): "THE PATIENT HAD A RIGHT THORACOTOMY/DECORTICATION SURGERY. THE SURGEON WAS USING SEVERAL OF THE PROGEL SYRINGES DURING THE CASE (PLEURAL AIR LEAK SEALANT). AS HE BEGAN TO INJECT THE PROGEL INTO THE CHEST CAVITY, ONE OF THE SYRINGES BROKE INSIDE THE SYRINGE CHAMBER. HE WAS UNABLE TO GET ANY PROGEL OUT OF THE TIP OF THE SYRINGE AT THIS POINT. A FEW SHARDS FROM THE SYRINGE LANDED ON THE STERILE DRAPE. THE CHEST CAVITY WAS INSPECTED AND NO SYRINGE SHARDS WERE FOUND. THE SYRINGE WAS IMMEDIATELY REMOVED FROM THE FIELD AND STERILITY MAINTAINED. NO HARM CAME TO THE PATIENT. POST-OPERATIVE CHEST X-RAY DOES NOT SHOW FOREIGN BODY IN PATIENT'S CHEST."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2027522 | PROGEL PLATINUM PLEURAL AIR LEAK SEALANT | SEALANT, POLYMERIZING | NBE | NEOMEND INC -2953195 | NA | IRFV0030 | 00801741010026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |